Relationship Between Sex Hormones, Postoperative Pain and Opioid Use: the Role of Immune Factors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postoperative Pain
- Sponsor
- Washington University School of Medicine
- Enrollment
- 210
- Locations
- 1
- Primary Endpoint
- Levels of IL-10 and IL-6
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
Aim 1- To identify relationships between sex hormone levels and postoperative pain and opioid use.
Aim 2: To determine whether the effects of testosterone on postoperative pain and opioid use are mediated by immune factors
Detailed Description
After signing the consent and assent forms, participants and their parents/guardians will complete several surveys, including demographic, behavioral, pain, substance use and analgesic risk assessment measures, and developmental surveys. In addition, a blood sample (for hormonal and immune analyses) will be collected on the day of the surgery and/or postoperative. Surgery-related parameters including postoperative pain, and opioid type and doses during the hospital time will be collected. In addition, before or after the surgery, patients and their parents/guardians will be interviewed. The interview will include questions about the surgery and about potential future study assessing the efficacy of sex hormone treatment on opioid use. Longitudinal measures. At routine follow-up with the surgeons or after 1 week, 1 month, 3 months, and 6 months, study staff will contact patients to inquire about persistent pain (location, severity), and persistent opioid use. Based on previous studies, we estimate that ∼30% will have persistent postoperative pain, and ∼5% will have persistent opioid use.After signing the consent and assent forms, participants and their parents/guardians will complete several surveys, including demographic, behavioral, pain, substance use and analgesic risk assessment measures, and developmental surveys. In addition, a blood sample (for hormonal and immune analyses) will be collected on the day of the surgery and/or postoperative. Surgery-related parameters including postoperative pain, and opioid type and doses during the hospital time will be collected. In addition, before or after the surgery, patients and their parents/guardians will be interviewed. The interview will include questions about the surgery and about potential future study assessing the efficacy of sex hormone treatment on opioid use. Longitudinal measures. At routine follow-up with the surgeons or after 1 week, 1 month, 3 months, and 6 months, study staff will contact patients to inquire about persistent pain (location, severity), and persistent opioid use. Based on previous studies, we estimate that ∼30% will have persistent postoperative pain, and ∼5% will have persistent opioid use.
Investigators
Hadas Nahman-Averbuch
Asst Prof of Anesthesiology
Washington University School of Medicine
Eligibility Criteria
Inclusion Criteria
- •Pediatric female patients between the ages 11-16 undergoing an orthopedic (trauma and non-trauma) surgical procedure involving a long bone or joint, or the spine, English speaking
Exclusion Criteria
- •Pregnancy; Diagnosis of chronic pain, Psychiatric, developmental or neurological disorders, Disorders that are associated with pubertal maturation (e.g., precocious puberty).
Outcomes
Primary Outcomes
Levels of IL-10 and IL-6
Time Frame: Baseline
Immune factors
Sex hormone level of estrogen
Time Frame: Baseline
Sex hormone level of Testosterone
Time Frame: Baseline
Sex hormone level of progesterone
Time Frame: Baseline